Clinical study design
8 important questions on Clinical study design
What are the different options on asking for consent when a patient is unconscious? (4)
- Deferred consent => acute and not highly invasive
- Asking next of kin (1. Curator/mentor 2. Written representative 3. Spouse 4. Parent, child, brother)
- Don't ask if it is a non-WMO study, database research => waiver
- Don't do the research
What are the restriction of a waiver consent?
- Working with numbers => no contact with patients, anonymous, the data/notes are not very clear
What is a challenge of treating patients at the ICU? How do they work with this currently?
So doctors don't really know what to do, how to treat a specific patient.
=>We classify patients into subphenotypes of syndromes for more precise treatment
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On what are current studies focussed at the ICU? And what do you want?
=> taking biomarker takes too much time.
Describe how subphenotypes are used in research to give the right treatment to the right patient in the ICU.
- Patient with ARDS => differ in cause, physiology, radiology, biology.
- Example of subtypes of physiology of ARDS= focal and non-focal ARDS.
- Based on the subtypes you can choose a ventilation method => randomize within your subgroup => randomize to corresponding strategy.
- You randomize to corresponding strategy because; when you wrongly account a specific strategy to a specific patient this could harm the patient.
Okay but you first have to discover relevant subtypes. How can you study this; study design.
=> you can use a database study => with a waiver.
What is you find a new biomarker, and you want to be sure that it is a good valid biomarker (for example for side effects) how do you test this?
How long does it take? What percentage goes wrong?
In these hypo- and hyperinflammatory subphenotypes, how to investigatemultiple interventions?
The question on the page originate from the summary of the following study material:
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